Contrast Enhancement Mammography vs MRI for the Surveillance of Women at High Risk of Breast Cancer: Con-trust Randomized Controlled Trial

Women at high risk of breast cancer (BC) should undergo annual magnetic resonance imaging (MRI) and digital mammography (DM) from at least ages 35 to 60. While MRI is an expensive and scarce resource, contrast-enhanced mammography (CEM) is a less costly and time-consuming alternative that could be used to screen these women instead of MRI. The Con-TRUST trial aims to randomize 1400 women in 10 centers to test whether CEM can be used instead of MRI+DM for BC detection in high-risk women (\>5% 5-year BC risk). The study will compare efficacy in reducing the incidence of BC in women who tested negative in the first screening and cumulative recall rates over 2 screening rounds. All women will be followed up for 2.5 years. Secondary outcomes include screening performance, safety, and women\'s compliance. The trial results will be integrated with the international literature and proposed for the development of recommendations as part of the adolopment of European guidelines in Italy.

NCT Number	NCT06629896
Lead Sponsor	Azienda USL Reggio Emilia - IRCCS Collaborators: Istituto Oncologico Veneto IRCCS, Azienda Ospedaliera Universitaria Policlinico "G. Martino", Azienda Ospedaliera Universitaria (AOU) Bari, Azienda Ospedaliera Universitaria Integrata Verona, Fondazione IRCCS Policlinico San Matteo di Pavia, Azienda Ospedaliero-Universitaria di Modena, Azienda USL della Romagna, Fondazione IRCCS Istituto Nazionale dei Tumori, Milano
Conditions	Breast Cancer Screening and Diagnosis
Enrollment	2,200 participants
Start Date	2025-02-01
Primary Completion	2028-07-07 (estimated)
Study Completion	2030-01-07 (estimated)
Updated on ClinicalTrials.gov	2026-05-07